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Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 430331

Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 430331 and sponsored by Qiagen Pty Ltd, manufactured by Qiagen GmbH in Germany. The device registration started on December 08, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
ARTG 430331
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 430331
Good Name: Qiagen Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
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Intended Purpose

IVDs for the qualitative detection of nucleic acid from SARS-CoV-2 in human clinical specimens

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
430331
Start Date
December 08, 2023
Effective Date
December 08, 2023
Sponsor
Manufacturer
Country
Germany
Address
Qiagen Str 1, Hilden, 40724